FDA.reportPublic FDA data

MicroFrance®

Primary DI
10381780089773
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
7828-16
Catalog number
7828-16
Device description
CURETTE 7828-16 16MM W/BASKET MOURE
Published
2017-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KBJCURETTE, ADENOID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBJCurette, AdenoidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780089773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178008977310381780089773

GMDN Terms#

Term, Definition table
TermDefinition
AdenotomeA hand-held manual surgical instrument designed to excise hypertrophic lymphoid tissue in the nasopharynx (i.e., pharyngeal tonsils or adenoids) during a procedure known as an adenoidectomy. It is typically a long, slender instrument with cutting blades at the working end, and a handle with a mechanism to operate the blades. It is available in various designs and sizes and may be a one-piece instrument or require the insertion of the blades into the handle. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
276593071
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780093558Integra® MicroFrance®CEV504A2016-09-21
10381780093565Integra® MicroFrance®CEV504B2016-09-21
10381780259367MicroFrance®CEV405UCEV405U2019-02-20
10381780259435MicroFrance®CEV531T3UCEV531T3U2019-02-20
10381780259503MicroFrance®CEV649B5UCEV649B5U2019-02-20
10381780259510MicroFrance®CEV649BGPUCEV649BGPU2019-02-20
10381780259572MicroFrance®CEV728BR5UCEV728BR5U2019-02-20
10381780259619MicroFrance®CEV8649B5UCEV8649B5U2019-02-20
10381780259626MicroFrance®CEV8649BGPUCEV8649BGPU2019-02-20
10381780259664MicroFrance®CEV891MUCEV891MU2019-02-20
10381780259695MicroFrance®CEV894MUCEV894MU2019-02-20
10381780259718MicroFrance®CEV895MUCEV895MU2019-02-20
10381780259794MicroFrance®CEV9649B5UCEV9649B5U2019-02-20
10381780259800MicroFrance®CEV9649BGPUCEV9649BGPU2019-02-20
10381780259879MicroFrance®CM107UCM107U2019-02-20
10381780259886MicroFrance®CM110UCM110U2019-02-20
10381780259893MicroFrance®CM111UCM111U2019-02-20
10381780259909MicroFrance®CM112UCM112U2019-02-20
10381780259916MicroFrance®CM113UCM113U2019-02-20
10381780259923MicroFrance®CM115UCM115U2019-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00194613048778MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048792MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048808MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048822MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048839MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048846MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048877MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613057329MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613068820MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613124014MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048709MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00194613048716MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00194613048761MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00194613048815MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00194613048860MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00840183507268BR Surgical, LLCBR Surgical, LLCKBJ2024-06-10
00840183512446BR Surgical, LLCBR Surgical, LLCKBJ2024-06-10
00840183512453BR Surgical, LLCBR Surgical, LLCKBJ2024-06-10
00840183512460BR Surgical, LLCBR Surgical, LLCKBJ2024-06-10
00190776390433MillenniumAvalign Technologies, Inc.KBJ2024-05-31
00842331194856Novo SurgicalNOVO SURGICAL, INC.KBJ2023-12-18
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G586E8249130Novo SurgicalNOVO SURGICAL, INC.KBJ2023-12-18
G586E8252220Novo SurgicalNOVO SURGICAL, INC.KBJ2023-12-18